BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTOA-FLEX

    MDR report key: 24489033 · Received March 2, 2026

    Report

    Report Number
    2518422-2026-007380
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 3, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005891
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE HAS BEEN MADE TO CORRECT 510K TO K131982.

    Description of Event or Problem · 0

    A REMSTAR AUTO A-FLEX WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM PARTICLES INSIDE THE BLOWER KIT AND BLOWER FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550078 REMSTAR AUTOA-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown